Comparison of Opioid Consumption During TCI Guided by NOL Index or Standard Care Undergoing Intracranial Tumor Surgery (NOLopioid)

June 19, 2023 updated by: Turkish Society of Anesthesiology and Reanimation

Comparison of Opioid Consumption During Target Controlled Infusion (TCI) Guided by Nociception Level Index (NOL) or Standard Care Undergoing Intracranial Tumor Surgery, Randomized Controlled Study

In this prospective, randomized controlled study, we hypothesized that nociception level index monitoring reduced opioid administration during surgery. The secondary goals are to compare the total dose hypnotic drugs, as well as hemodynamic parameters, and to investigate the relationship between changes in the NOL index and HR change following severe noxious stimuli during effect site TCI of propofol and remifentanil in patients undergoing intracranial tumor surgery who are monitored using either standard monitors or the NOL monitor additionally.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted on 50 patients aged between 18-75 years, with the American Society of Anesthesiologists (ASA) classification II-III, who would undergo intracranial tumor surgery after ethics committee approval (08/09/2020, 2020-15/15) and written consent from the patients. Standard monitoring (invasive arterial monitoring, 5-lead ECG, peripheral oxygen saturation-SpO2) and Bispectral Index Score (BIS) monitoring will be performed in the standard care group (SC; n=25), and NOL index monitoring will be performed in addition to standard monitors in the NOL guided group (NOL-G; n=25).

During TCI, propofol (Schnider) effect-site concentration (Ce) will be titrated to BIS score between 40-60 and remifentanil (Minto) Ce to standard hemodynamic parameters in the SC group and NOL index between 10-25 in the NOL-G group.

In all patients, Systolic, Diastolic and Mean Arterial Pressure (SAP, DAP, MAP), Heart Rate (HR), SpO2, BIS scores will be recorded before induction, intubation, head holder pinning, skin incision, muscle and periosteal dissection, craniotomy, dural incision, tumor excision, dural suturation, muscle and periosteum suturation, skin suturation, and interruption of infusions. In addition, NOL index in the NOL-G group patients will be recorded in all that time.

Hemodynamic parameters, to be administered propofol and remifentanil doses will be compared in two groups. NOL index changes before and after intubation, head holder pinning, skin incision and craniotomy, which are determined as severe noxious stimuli, will be compared with changes in HR.

Traditionally, the hemodynamic reactivity such as increased HR and blood pressure (BP), and/or nocifensive movements in the absence of paralytic agents are clinically considered for the assessment of nociception. The response to nociceptive stimuli is monitored as an increase in sympathetic or a decrease in parasympathetic tone (Guignard, 2006). The sympathetic response generates physiological changes such as increased HR, increased peripheral vasoconstriction, pupillary dilation, and changes in galvanic skin conductance (Guignard, 2006). As the understanding of nociception has grown in the past two decades, the industry has developed various nociception detecting devices based on some of the mentioned parameters.The only multi-parameter device is the Nociception Level (NOL) index (Ledowski, 2019). Evidence suggests the multi-parameter approach may be superior to the single-parameter approach for the assessment of nociceptive pain induced by tonic heat stimuli among healthy volunteers (Treister et al., 2012)

The PMD-200 system (NOL device) consists of a display and computing unit, a reusable non-invasive finger probe and a single-use sensor.The proprietary signal acquisition sensor platform (the combination of the finger probe and the single-use sensor) acquires physiological signals. Using advanced algorithms, the system processes and analyses multiple nociception related physiological parameters and their various derivatives, which correspond with the sympathetic nervous system's response to noxious stimuli. The finger probe and single-use sensor continuously acquire four physiological signals through the following four sensors; photoplethysmograph (PPG), galvanic Skin Response (GSR), peripheral Temperature (Temp), accelerometer (ACC). From these four signals the NOL algorithm extracts and analyses nociception-related physiological parameters and derivatives: pulse rate, pulse rate variability, pulse wave amplitude, skin conductance level, peripheral temperature, movement, and their various derivatives. Then a patient's specific nociception signature is established and continuously monitored. Peripheral temperature and movement serve as guardrails supporting algorithm validity and do not contribute directly to the algorithm calculation.

In 2013, Ben-Israel et al., published the first study on the multiparametric Nociception Level index (NOL). The few validation studies to date allowed the preliminary conclusion that the NOL index presented as an accurate means to measure the level of nociception during general anesthesia (Edry et al., 2016) . On the other hand, there are studies showing that the NOL index monitor does not reduce opioid consumption, or even though it does, there is no significant difference (Espitalier et al., 2021; F. Meijer et al., 2020; Niebhagen et al., 2022; Renaud-Roy et al., 2022) In addition, many studies in the literature indicate that NOL index monitoring is a reliable monitor in the evaluation of nociception or in distinguishing noxius stimuli (Renaud-Roy et al., 2019) (Treister et al., 2012) (Edry et al., 2016) (Martini et al., 2015) (Bollag et al., 2018) .

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Nilufer
      • Bursa, Nilufer, Turkey, 16140
        • Uludag University Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • İntracranial mass surgery
  • Craniotomy
  • ASA II-II
  • elective surgery

Exclusion Criteria:

  • pregnant or suspected of pregnancy
  • receive antiarrhythmic therapy
  • autonomic nervous system disease
  • ASA IV
  • emergency surgery
  • patients with difficult airway features
  • patients receiving chronic pain treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
standard care group
Active Comparator: study group
NOL guided group
Device: Nociception Leve Indeks
During TIVA-TCI, propofol (Schnider) effect site concentration (Ce) was titrated to BIS score between 40-60 and remifentanil (Minto) Ce to standard hemodynamic parameters in the control group and NOL index value between 10-25 in the study group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of administered remifentanil doses (mcg/kg/min)
Time Frame: throughout the operation

This data will be obtained from the TCI device. Demographic data such as the patient's gender, age, weight, etc. are entered into the TCI device. The TCI device displays the total duration of the operation as hour and the total amount of drug used as microgram.

To control for patient weight and duration of surgery, we report the anesthesia drug doses as dose/kg/min of anesthesia time.The remifentanil administration dose is indicated in mcg/kg/min.

"kg" is patient's actual body weight. "min" is operating time in minutes.
throughout the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of administered propofol dose (mg/kg/min)
Time Frame: throughout the operation

This data will be obtained from the TCI device. Demographic data such as the patient's gender, age, weight, etc. are entered into the TCI device. The TCI device displays the total duration of the operation as hour and the total amount of drug used as milligram.

To control for patient weight and duration of surgery, we report the anesthesia drug doses as dose/kg/min of anesthesia time. The propofol administration dose is indicated in mg/kg/min.

"kg" is patient's actual body weight. "min" is operating time in minutes.
throughout the operation
comparison of hemodynamic parameters
Time Frame: throughout the operation

Standard (invasive arterial monitoring, 5-lead ECG, peripheral oxygen saturation-SpO2) and BIS monitoring will be performed in the SC group, and NOL index monitoring will be performed in addition to standart monitors in the NOL-G group.

SAP, DAP, MAP, HR will be recorded before induction (T0), intubation (T1), head holder pinning (T2), skin incision (T3), muscle and periosteal dissection (T4), craniotomy (T5), dural incision (T6), tumor excision (T7), dural suturation (T8), muscle and periosteum suturation(T9), skin suturation (T10), and interruption of infusions (T11).

Hemodynamic parameters and BIS score are recorded on the anesthesia device monitor.

SAP, DAP, MAP are defined as mmhg. HR is defined as beat per minute BIS score and NOL index give an index between 0-100. NOL index device saves data itself and this data can be exported via flash memory.
throughout the operation
comparison of variability NOL index during severe noxious stimuli
Time Frame: throughout the operation

NOL index changes before and after intubation, head holder pinning, skin incision, and craniotomy, which were determined and compared as severe noxious stimuli.

The NOL index device records the heart rate and the NOL index every 5 seconds.
throughout the operation
comparison of variability Heart rate during severe noxious stimuli
Time Frame: throughout the operation

Heart rate changes before and after intubation, head holder pinning, skin incision, and craniotomy, which were determined and compared as severe noxious stimuli.

The NOL index device records the heart rate and the NOL index every 5 seconds.
throughout the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish Society of Anesthesiology and Reanimation

Collaborators

Uludag University

Investigators

  • Study Director: Hulya Bilgin, Bursa Uludağ University Faculty of Medicine Department of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Actual)

October 2, 2022

Study Completion (Estimated)

August 30, 2023

Study Registration Dates

First Submitted

January 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOLguidedopioid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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